Clinical trial • Phase II • Haematology|Rare Disease

ELRITERCEPT for Myelofibrosis|Primary myelofibrosis|Post-polycythaemia vera myelofibrosis|Post-essential thrombocythemia myelofibrosis

Phase II trial of ELRITERCEPT for Myelofibrosis|Primary myelofibrosis|Post-polycythaemia vera myelofibrosis|Post-essential thrombocythemia myelofibrosis.

Overview

Trial Therapeutic Area
Haematology|Rare Disease
Trial Disease
Myelofibrosis|Primary myelofibrosis|Post-polycythaemia vera myelofibrosis|Post-essential thrombocythemia myelofibrosis
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme|Small molecule

Key dates

Initial CTIS Submission Date
02-08-2024
First CTIS Authorization Date
02-09-2024

Trial design

open-label, ruxolitinib (jakavi; marketed tablet formulations 5 mg, 10 mg, 20 mg) — oral; used as comparator/concomitant therapy in arms 1b and 2b. specific per-participant dosing schedule not detailed in provided text (participants on stable ruxolitinib dose ≥4 weeks prior to c1d1).-controlled, adaptive Phase II trial across 22 sites in Italy, Spain, France.

Open Label
Yes
Comparator
Ruxolitinib (Jakavi; marketed tablet formulations 5 mg, 10 mg, 20 mg) — oral; used as comparator/concomitant therapy in Arms 1B and 2B. Specific per-participant dosing schedule not detailed in provided text (participants on stable ruxolitinib dose ≥4 weeks prior to C1D1).
Adaptive
True, dose escalation elements described: Part 1 is dose escalation of elritercept (ascending doses) with safety and DLT monitoring to determine recommended Phase 2 dose(s) (RP2D). Interim safety assessments and DLT evaluation drive escalation decisions.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
65

Eligibility

Recruits 65 Vulnerable population selected (isVulnerablePopulationSelected=true). Participants must be adults (≥18 years) and sign written informed consent. No paediatric assent or proxy-consent procedures are specified in the provided text; consent materials and ICFs are available (multiple language versions) but no further vulnerable-population consent details are provided..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected=true). Participants must be adults (≥18 years) and sign written informed consent. No paediatric assent or proxy-consent procedures are specified in the provided text; consent materials and ICFs are available (multiple language versions) but no further vulnerable-population consent details are provided.

Inclusion criteria

  • {"criterion_text":"- Male or female ≥18 years of age, at the time of signing informed consent."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance score ≤2."}
  • {"criterion_text":"- Life expectancy ≥12 months per Investigator assessment"}
  • {"criterion_text":"- Confirmed diagnosis of PMF (prefibrotic or overtly fibrotic) according to the 2016 World Health Organization (WHO) criteria (see Appendix 3), post-PV MF, or post-ET MF according to the 2008 International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWGMRT) criteria (see Appendix 4)."}
  • {"criterion_text":"- Anemia, defined as: a. Having received ≥6 units of RBC transfusion for Hgb ≤8.5 g/dL in the 12 weeks prior to the planned C1D1, including ≥1 unit of RBC transfusion in the 28 days prior to C1D1; or b. Having ≥3 evaluable Hgb measurements at <10.0 g/dL including ≥1 evaluable Hgb measurement assessed 8 to 13 weeks prior to C1D1. with or without receiving RBC transfusions to be evaluated for anemia criterion “b.”, partecipants receiving RBC transusion must meet the below parameters: i. All pre-transfusion Hgb values (defined as a Hgb assessed within the 3 days prior to a transfusion) should be recorded, and ≥1 pre-transfusion Hgb value is required. ii. Hgb values collected within the 28 days following a transfusion will not be considered evaluable unless qualifying as a pre-transfusion Hgb; in cases where multiple transfusions are given in succession due to poor Hgb response, only the first pre-transfusion Hgb will be considered evaluable."}
  • {"criterion_text":"- Arm-specific criteria: Arm 1A and 2A: - a. Previously treated with JAK inhibitor(s) and, per the Investigator, discontinued due to one of the following reasons: i. Relapsed disease following treatment with JAK inhibitor(s) ii. Refractory to treatment with JAK inhibitor(s) iii. Intolerance to treatment with JAK inhibitor(s) iv. Participant no longer met risk/benefit ratio to continue JAK inhibitor(s) OR v. Participant with prognostic score of intermediate-1 or higher Dynamic International Prognostic Scoring System (DIPSS) and is ineligible for JAK inhibitor(s) in the opinion of the Investigator b.Participants previously treated with JAK inhibitor(s) must have discontinued JAK inhibitor therapy ≥8 weeks before C1D1"}
  • {"criterion_text":"- Arms 1B and 2B: a.Has been receiving ruxolitinib prescribed for a diagnosis of PMF (prefibrotic or overtly fibrotic), post-PV MF, or post-ET MF for ≥8 weeks prior to C1D1 and on a stable dose for ≥4 weeks prior to C1D1. In Arm 2B only, at least 10 participants should have been on ruxolitinib for <6 months prior to C1D1. b.Meets ≥1 of the following criteria in the opinion of the Investigator: - Current ruxolitinib treatment is considered to be providing insufficient control of the disease i.The participant's cytopenias are limiting the participant's ruxolitinib dose intensity ii.The participant's disease is symptomatic and warrants additional therapy"}
  • {"criterion_text":"- Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception as described in the protocol."}

Exclusion criteria

  • {"criterion_text":"- Medical History:1. Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed."}
  • {"criterion_text":"- Diagnosis of hemolytic anemia, active bleeding, hemoglobinopathies, or congenital disorders as a cause of the participant's anemia."}
  • {"criterion_text":"- NCI CTCAE Grade ≥2 bleeding events within the 3 months prior to C1D1."}
  • {"criterion_text":"- Receipt of an RBC or platelet transfusion for any reason(s) or combination of reasons other than underlying MF within the 12 weeks prior to C1D1. If a participant requires a transfusion for an unanticipated reason during the Pretreatment Period, a prolonged screening period may be considered after discussion with the Medical Monitor."}
  • {"criterion_text":"- Prior treatment with luspatercept, sotatercept, or other commercially available or investigational transforming growth factor (TGF)-β inhibitors (all arms)."}
  • {"criterion_text":"- Treatment within 28 days prior to C1D1 with: a. Erythropoiesis-stimulating agent b. Granulocyte colony-stimulating factor c. Granulocyte-macrophage colony-stimulating factor d. Thrombopoietin agonists e. Immunomodulator imide drugs (e.g., thalidomide, pomalidomide, lenalidomide) f. Interferon g. Hydroxyurea h. Steroids at doses exceeding corticosteroid equivalent of 10 mg/day prednisone"}
  • {"criterion_text":"- Newly initiated iron chelation therapy within the 8 weeks prior to C1D1. Stable doses of iron chelators are allowed if prescribed per label."}
  • {"criterion_text":"- Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed."}
  • {"criterion_text":"- Treatment with another investigational drug or device or approved therapy for the treatment of MF or anemia in MF ≤28 days prior to C1D1, or, if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer."}
  • {"criterion_text":"- For Arms 1B and 2B (participants receiving ruxolitinib), initiation of treatment with strong cytochrome P450 (CYP)3A4 inhibitors within 2 weeks prior to C1D1. Participants receiving CYP3A4 inhibitors/inducers as concomitant therapy with ruxolitinib in accordance with ruxolitinib local prescribing information may continue to receive such therapies in this study."}
  • {"criterion_text":"- Bone marrow aspirate blast percentage >5% a. In the event of a non-evaluable pretreatment bone marrow aspirate expected to be due to marrow fibrosis, participants may be enrolled without bone marrow aspirate blast percentage data if all other eligibility criteria are met. Historical bone marrow data may be requested to support confirmation of diagnosis."}
  • {"criterion_text":"- Presence of the following cardiac conditions: a. New York Heart Association Class 3 or 4 heart failure b. QTcF (QT interval corrected by Fridericia's formula) >500 msec on the screening or C1D1 electrocardiogram (ECG; mean of 3 measurements) c. Uncontrolled clinically significant arrhythmia (participants with ratecontrolled atrial fibrillation are not excluded) d. Acute myocardial infarction or unstable angina pectoris ≤6 months prior to C1D1"}
  • {"criterion_text":"- Peripheral blood blast percentage ≥10%"}
  • {"criterion_text":"- Estimated glomerular filtration rate <30 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration equation)"}
  • {"criterion_text":"- Body mass index (BMI) ≥40 kg/m2."}
  • {"criterion_text":"- Presence of uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg despite adequate treatment."}
  • {"criterion_text":"- History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years."}
  • {"criterion_text":"- History of stroke, deep venous thrombosis, or arterial embolism within 6 months prior to C1D1."}
  • {"criterion_text":"- Any malignancy other than PMF, post-ET MF, or post-PV MF that has not been in remission and/or has required systemic therapy including radiation, chemotherapy, hormonal therapy, or biologic therapy, within 1 year prior to C1D1. In situ cancers, squamous cell and basal cell carcinomas, and monoclonal gammopathy of unclear significance are allowed at the discretion of the Investigator."}
  • {"criterion_text":"- History of solid organ or hematological transplantation."}
  • {"criterion_text":"- History of severe allergic or anaphylactic reaction(s) or hypersensitivity to recombinant proteins or excipients in the investigational drug, or ruxolitinib for participants enrolling in Arm 1B or 2B."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part 1 Dose Escalation: •Safety and tolerability as determined by the incidence of adverse events (AEs), including dose-limiting toxicities (DLTs), severe AEs, and serious AEs (SAEs)","definition_or_measurement_approach":"Measured by incidence and classification of AEs, including identification of DLTs, severe AEs and SAEs during Part 1 dose escalation."}
  • {"endpoint_text":"- Part 2 Dose Expansion: •Safety and tolerability as determined by the incidence of AEs, including severe AEs and SAEs","definition_or_measurement_approach":"Measured by incidence and classification of AEs, including severe AEs and SAEs during Part 2 dose expansion."}
  • {"endpoint_text":"- Long-Term Extension: •Safety and tolerability as determined by the incidence of AEs, including severe AEs and SAEs over time","definition_or_measurement_approach":"Longitudinal measurement of incidence of AEs, severe AEs and SAEs over the long-term extension follow-up period."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants with progression to AML","definition_or_measurement_approach":"Proportion of participants meeting criteria for progression to acute myeloid leukemia (AML) as defined in protocol."}
  • {"endpoint_text":"- Proportion of participants with progression to accelerated MF","definition_or_measurement_approach":"Proportion of participants meeting protocol-defined criteria for progression to accelerated myelofibrosis."}
  • {"endpoint_text":"- Subgroup of participants with anemia requiring red blood cell (RBC) transfusions (See Table 3 in Protocol KER050-MF-301 v 6.0).","definition_or_measurement_approach":"Analysis of the predefined subgroup of participants who require RBC transfusions per protocol definitions (see protocol Table 3)."}
  • {"endpoint_text":"- Subgroup of transfusion-independent participants (and, when appropriate, the subgroup of participants with anemia requiring RBC transfusions who are deemed not evaluable for assessment of transfusion independence) (See Table 3 Protocol KER050-MF-301 v 6.0).","definition_or_measurement_approach":"Assessment of transfusion independence per protocol definitions (see protocol Table 3)."}
  • {"endpoint_text":"- Proportion of participants with improvement in the MF-SAF (v4.0)-TSS of ≥50% from baseline at Week 24","definition_or_measurement_approach":"Measured by change from baseline in MF-SAF v4.0 total symptom score (TSS); proportion achieving ≥50% reduction at Week 24."}
  • {"endpoint_text":"- Proportion of participants with decrease in spleen volume of ≥35% from baseline as measured by computed tomography/magnetic resonance imaging (CT/MRI) at Week 24 (excluding participants’ status post splenectomy or splenic irradiation)","definition_or_measurement_approach":"Measured by CT or MRI volumetric assessment of spleen; proportion with ≥35% spleen volume reduction at Week 24; excludes post-splenectomy/splenic irradiation status."}
  • {"endpoint_text":"- Plasma concentrations of elritercept","definition_or_measurement_approach":"Pharmacokinetic measurement of plasma elritercept concentrations at specified timepoints."}
  • {"endpoint_text":"- Maximum observed serum concentration (Cmax), time to maximum observed concentration (Tmax), and area under the concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-last; Cycle 1 only)","definition_or_measurement_approach":"Standard PK parameters (Cmax, Tmax, AUC0-last) evaluated in Cycle 1 per PK sampling schedule."}
  • {"endpoint_text":"- Minimum observed serum concentration (Cmin) and accumulation rate (Rac)","definition_or_measurement_approach":"PK parameters including Cmin and accumulation ratio (Rac) per protocol PK analyses."}
  • {"endpoint_text":"- Change from baseline of red cell parameters, including reticulocyte count, Hgb, mean corpuscular volume, mean corpuscular hemoglobin, and reticulocyte cell Hgb by visit","definition_or_measurement_approach":"Laboratory-based assessments of red cell indices and reticulocyte parameters with change-from-baseline analyses by visit."}

Recruitment

Planned Sample Size
65
Recruitment Window Months
86
Consent Approach
Written informed consent required from each participant (inclusion criteria: 'at the time of signing informed consent' and participants are ≥18). ICFs and subject information sheets are provided (multiple language versions available including English, French, Spanish, Italian as evidenced by language-specific documents). Females of childbearing potential and sexually active males must agree to use highly effective contraception as described in the protocol. No paediatric assent or proxy consent procedures are provided in the supplied material.

Methods

  • Physician referral letters (documented K2_Physician Referral Letter_Public / country-specific versions) targeted at treating physicians/hematologists.
  • Participant brochures and study guides (K3/ K4 Participant Brochure / Participant Study Guide) provided to potential participants.
  • GP / Letter to patient-doctor communications (country-specific recruitment materials) to support referral.
  • Patient information sheets and informed consent materials (L1 SIS and ICF main and language variants) provided to prospective participants.
  • Public-facing recruitment arrangements documents (K1 Recruitment Arrangements) prepared per country (France/Italy/Spain versions present).

Geography

Total Number Of Sites
22
Total Number Of Participants
47

Italy

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
490
Number Of Sites
12
Number Of Participants
28

Sites

Site Name
Careggi University Hospital
Department Name
Department of Experimental and Clinical Medicine
Principal Investigator Name
Alessandro Maria Vannucchi
Principal Investigator Email
amvannucchi@unifi.it
Contact Person Name
Alessandro Maria Vannucchi
Contact Person Email
amvannucchi@unifi.it
Site Name
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Department Name
Hematology and Stem Cell Transplantation Unit
Principal Investigator Name
Pellegrino Musto
Principal Investigator Email
pellegrino.musto@uniba.it
Contact Person Name
Pellegrino Musto
Contact Person Email
pellegrino.musto@uniba.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Hematology
Principal Investigator Name
Massimo Breccia
Principal Investigator Email
breccia@bce.uniroma1.it
Contact Person Name
Massimo Breccia
Contact Person Email
breccia@bce.uniroma1.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Dpt. of Medicine, Sect. of Hematology
Principal Investigator Name
Massimiliano Bonifacio
Principal Investigator Email
massimiliano.bonifacio@univr.it
Contact Person Name
Massimiliano Bonifacio
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Hematology and cell therapies Unit
Principal Investigator Name
Marica Laurino
Principal Investigator Email
marica.laurino@hsanmartino.it
Contact Person Name
Marica Laurino
Contact Person Email
marica.laurino@hsanmartino.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Hematology Division
Principal Investigator Name
Marianna Caramella
Principal Investigator Email
marianna.caramella@ospedaleniguarda.it
Contact Person Name
Marianna Caramella
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
Hematology
Principal Investigator Name
Marco Brociner
Principal Investigator Email
marco.brociner@asst-settelaghi.it
Contact Person Name
Marco Brociner
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Division of Hematology
Principal Investigator Name
Mariella D'Adda
Principal Investigator Email
mariella.dadda@asst-spedalicivili.it
Contact Person Name
Mariella D'Adda
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
HEMATOLOGY SERVICE AND DH Unit
Principal Investigator Name
Valerio De Stefano
Principal Investigator Email
Valerio.destefano@unicatt.it
Contact Person Name
Valerio De Stefano
Contact Person Email
Valerio.destefano@unicatt.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Unit of Hematology
Principal Investigator Name
Francesca Palandri
Principal Investigator Email
francesca.palandri@unibo.it
Contact Person Name
Francesca Palandri
Contact Person Email
francesca.palandri@unibo.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Hematology Unit
Principal Investigator Name
Alessia Tieghi
Principal Investigator Email
alessia.tieghi@ausl.re.it
Contact Person Name
Alessia Tieghi
Contact Person Email
alessia.tieghi@ausl.re.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Hematology Unit
Principal Investigator Name
Alessandra Iurlo
Principal Investigator Email
alessandra.iurlo@policlinico.mi.it
Contact Person Name
Alessandra Iurlo

Spain

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
465
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
Hospital Universitario La Paz
Department Name
Hematology
Principal Investigator Name
Mercedes Gasior
Principal Investigator Email
mercedesgasior@gmail.com
Contact Person Name
Mercedes Gasior
Contact Person Email
mercedesgasior@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematology
Principal Investigator Name
Juan Carlos Hernandez Boluda
Principal Investigator Email
hernandez_jca@gva.es
Contact Person Name
Juan Carlos Hernandez Boluda
Contact Person Email
hernandez_jca@gva.es
Site Name
Hospital Universitario De La Princesa
Department Name
Hematology
Principal Investigator Name
Javier Loscertales
Principal Investigator Email
jloscertales@gmail.com
Contact Person Name
Javier Loscertales
Contact Person Email
jloscertales@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Hematology
Principal Investigator Name
Blanca Xicoy Cirici
Principal Investigator Email
bxicoy@iconcologia.net
Contact Person Name
Blanca Xicoy Cirici
Contact Person Email
bxicoy@iconcologia.net
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Jesús María Hernandez Rivas
Principal Investigator Email
jmhr@usal.es
Contact Person Name
Jesús María Hernandez Rivas
Contact Person Email
jmhr@usal.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Mª Laura Fox
Principal Investigator Email
mlfox@vhio.net
Contact Person Name
Mª Laura Fox
Contact Person Email
mlfox@vhio.net
Site Name
Hospital Quironsalud Zaragoza
Department Name
Hematology
Principal Investigator Name
Pilar Giraldo
Principal Investigator Email
giraldocastellano@gmail.com
Contact Person Name
Pilar Giraldo
Contact Person Email
giraldocastellano@gmail.com

France

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
569
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Hospices Civils De Lyon
Department Name
Service hématologie Clinique
Principal Investigator Name
Fiorenza BARRACO
Principal Investigator Email
fiorenza.barraco@chu-lyon.fr
Contact Person Name
Fiorenza BARRACO
Contact Person Email
fiorenza.barraco@chu-lyon.fr
Site Name
Hopital Prive Sevigne
Department Name
Service d'Hématologie
Principal Investigator Name
Benoit BAREAU
Principal Investigator Email
benoit.bareau@gmail.com
Contact Person Name
Benoit BAREAU
Contact Person Email
benoit.bareau@gmail.com
Site Name
Oncoradio Centre Oncogard
Department Name
Service Hématologie Clinique et Oncologie Médicale
Principal Investigator Name
Stefan WICKENHAUSER
Principal Investigator Email
stefan.wickenhauser@chu-nimes.fr
Contact Person Name
Stefan WICKENHAUSER

Sponsor

Primary sponsor

Full Name
Takeda Development Center Americas Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Almac Clinical Services LLC
Responsibilities
Duties include codes [14] and [3] in sponsorDuties (detailed responsibilities not fully enumerated in supplied data); contact clinicalservices@almacgroup.com
Name
Pharmaron (US) Clinical Services Inc.
Responsibilities
Duties include code [10] (bd@pharmaron.com)
Name
Iqvia Biotech Limited
Responsibilities
Multiple operational roles (sponsorDuties codes [1,12,2,5,8]); contact eu_clinical_trials_information@iqvia.com
Name
PPD Development LP
Responsibilities
PK analysis testing
Name
Q Squared Solutions Limited
Responsibilities
Central Laboratory Services and other operational roles
Name
Azenta US Inc.
Responsibilities
Long term sample storage
Name
Rad Md LLC
Responsibilities
Imaging
Name
Cellcarta Biosciences Inc.
Responsibilities
Exploratory biomarker analysis

Third parties

  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: [14] (no text provided for code)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaron (US) Clinical Services Inc.","duties_or_roles":"sponsorDuties codes: [10]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Rad Md LLC","duties_or_roles":"Imaging (sponsorDuties code 15, value: Imaging)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term sample storage (sponsorDuties code 15, value: Long term sample storage)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"sponsorDuties codes: [1, 12, 2, 5, 8] (roles listed by code; contact email eu_clinical_trials_information@iqvia.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"PK analysis testing (sponsorDuties code 15, value: PK analysis testing)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: [10, 15, 4] with value 'Central Laboratory Services' and others","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"exploratory biomarker analysis (sponsorDuties code 15, value: exploratory biomarker analysis)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC (second entry)","duties_or_roles":"sponsorDuties codes: [14, 3]","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Viedoc Technologies AB","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Australia","full_name":"Peter Maccallum Cancer Institute","duties_or_roles":"Bone Marrow/Peripheral blood sampling (sponsorDuties code 15, value: Bone Marrow/Peripheral blood sampling)","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
elritercept (KER-050)
Active Substance
ELRITERCEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
prodAuthStatus=1 (not marketed/authorisation status: 1 in dataset)
Maximum Dose
5 mg/kg (maxDailyDoseAmount: 5 mg/kg)
Investigational Product Name
Ruxolitinib (Jakavi; comparator)
Active Substance
RUXOLITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus=2 (marketing authorisation entries present in dataset)
Maximum Dose
Max daily dose amount indicated in product entries: 50 mg
Combination Treatment
Yes

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